This invention relates to protective containers. More specifically, the present invention relates to a catheter protection, preparation and dispensing package.
The invention is particularly applicable to a package designed for holding an intravascular catheter which is adapted for insertion into a vein of a patient, such as a Swan-Ganz brand balloon flotation catheter sold by American Edwards Laboratories, American Hospital Supply Corporation of Evanston, Ill. (Swan-Ganz is a registered trademark). This catheter has a plurality of lumens which allow for injection of various substances into the patient and allows various readings to be made within the vascular system of the patient, such as pressure and temperature readings. It should, however, be appreciated that the package disclosed herein can also be adapted for use in a variety of other catheter packaging environments.
The insertion of vascular catheters, such as balloon flotation catheters, into a patient, requires an absolutely sterile procedure since it is well known that catheter contamination during preparation and insertion of the catheter is a cause of life-threatening infections. Because conventional balloon flotation catheters are long, generally greater than 100 cm for an adult patient, and unwieldy, it is difficult to keep them sterile.
Because of its length and resilient nature, a balloon flotation catheter is cumbersome to control in a limited sterile field after it is removed from its package. Moreover, considerable preparation and testing needs to be done on an exposed catheter prior to its insertion. The present art requires flotation catheters to be exposed to a potentially contaminating environment during preparation, testing and insertion. Previously, a wide area was draped so as to be sterile, along with the operators themselves, so that it made no difference as to how the catheter was handled. Now, while the operators themselves remain sterile, a wide area is not necessarily sterile. Consequently there are many potential sources of contamination during this testing procedure.
Additionally, the procedure requires that a technician be ready at all times in order to assist the physician immediately as needed with the check-out process. While the check-out of the catheter is taking place, of course, the physician has to wait, thereby taking up the physician's time. While all of this is happening, contaminating micro-organisms may enter the sterile field and contaminate the catheter. This could potentially produce life-threatening infections.
Presently, the catheter is disengaged from an ordinary non-compartmentalized package and the terminals for the catheter lumens are attached to their respective tubing connections. Subsequently, some of the catheter ducts are flushed with a saline or heparin solution to avoid clot formation within the lumens or an air embolism in the patient after insertion of the catheter. A sterile sleeve is thereafter pulled over a balloon end of the catheter to provide a protective covering to be used while the catheter is in-dwelling in the patient after the insertion procedure.
A balloon at the distal end of the catheter is sometimes inflated to test for air leaks since catheter insertion is potentially more dangerous if the balloon does not remain inflated. Additionally, an air leak in the balloon may necessitate a second cardiac catheterization with its attendant risk. After the balloon has been tested, the catheter is inserted into an introducer which has previously been placed into a vein of the patient.
The catheter is then passed into a blood vessel of the patient and is advanced through the blood vessel. The inflated balloon draws the catheter tip in the direction of blood flow, and the pressure waveform is used to identify tip location. The catheter is then secured in the desired location and a portion of the catheter extending from the introducer is covered by the protective sleeve in order to maintain this portion in a sterile condition. This length, which may be as long as 40 cm, can be advanced easily into the vein if the catheter has to be moved because it dislodges or migrates.
An improvement over the conventional catheter package is a package having four separately openable lids enclosing various compartments. A smaller compartment contains a proximal end of the catheter including the hubs and allows the connection and flushing of the catheter prior to insertion thereof. A trough covered by two separate lids houses a distal end of the catheter and a pleated glove thereon. A larger compartment contains a main portion of the catheter. A lid for the larger compartment only extends over a relatively small portion of the larger compartment and it is intended that the catheter be pulled out therethrough. The entire assembly is then enclosed in a separate outer bag. This known package is, however, impractical from the standpoint that it is too complex, and therefore expensive to manufacture as well as being difficult to use. It would be desirable to provide a relatively simple compartmented catheter package which would be inexpensive to manufacture and yet provide the advantages of ease of check-out, without the necessity for several people to be occupied with or waiting for this task, ease of removal of the catheter from the package, and assurance of the sterility of an indwelling portion of the catheter until removal.
Accordingly, it has been considered desirable to develop a new and improved catheter preparation and dispensing package which would overcome the foregoing difficulties and others while providing better and more advantageous overall results.